Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device |
510(K) Number |
K990380 |
Device Name |
System, Measurement, Blood-Pressure, Non-Invasive |
Applicant |
MEDITEC CO., LTD.
#206 GADONG, SUNNAM APT FACTO
YATAPDONG, BUNGDANGGU
SUNNAMCITY, KYUNGGIDO 463-070 KR
Other 510(k) Applications for this Company
|
Regulation Number |
870.1130
More FDA Info for this Regulation Number |
Classification Product Code |
DXN
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
02/08/1999 |
Decision Date |
02/22/1999 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
CV - Cardiovascular |
Review Advisory Committee |
CV - Cardiovascular |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
Y |
Expedited Review |
|